EndometriosisNCT00462176
Laparoscopic Segmental Bowel Resection for Deep Infiltrating Colorectal Endometriosis
An observational study of Endometriosis, run by University Hospital, Gasthuisberg at 1 site in Belgium.
Trial summary
This study is executed to evaluate the outcome on quality of life, pain, sexuality, pregnancy rate and recurrence rate after a fertility sparing multidisciplinary CO2 laser laparoscopic radical excision of deep infiltrating colorectal endometriosis with a bowel resection. Read more about this study
- Who is it for?
- Ages 19 to 43 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- multidisciplinary laparoscopy and Questionnaires
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2004to Feb 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 43 years
- Women only
- No healthy volunteers
- Adult
Study population: All women (n=45) who had undergone CO2 laser laparoscopic radical excision of deep infiltrating endometriosis with active involvement of the colorectal surgeon performing a bowel resection were selected retrospectively from the list of all patients (n=more than 400) operated at the Leuven University Fertility Centre (LUFc) between September 2004 and July 2006.
Who may be able to join
- Patients suffering from deep infiltrating endometriosis with colorectal extension
- Who had undergone CO2 laser laparoscopic radical excision of the endometriosis
- with bowel resection performed by the colorectal surgeon
- between September 2004 and July 2006.
Who cannot join
- Patients without bowel resection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Follow-up of Patients After Laparoscopic Segmental Bowel Resection for Deep Infiltrating Colorectal Endometriosis
This study is executed to evaluate the outcome on quality of life, pain, sexuality, pregnancy rate and recurrence rate after a fertility sparing multidisciplinary CO2 laser laparoscopic radical excision of deep infiltrating colorectal endometriosis with a bowel resection.
Read the detailed description
Patients
All women (n=45) who had undergone fertility sparing CO2 laser laparoscopic radical excision of deep infiltrating endometriosis with bowel resection were selected retrospectively from the list of all patients (n=more than 500, of whom slightly more than 50% with endometriosis) operated at the Leuven University Fertility Centre (LUFc) between September 2004 and September 2006.
Questionnaires
All 45 patients were asked to complete the Oxford Endometriosis Quality of Life questionnaire (27), a sexual activity questionnaire (28), visual analogue scales (VAS) for dysmenorroe, chronic pelvic pain and deep dyspareunia, and to answer questions about medication and fertility, to compare their status before surgery and at the moment of the evaluation (December 2008).
- Conditions
- Endometriosis
- Being tested
- multidisciplinary laparoscopy, Questionnaires
- Keywords
- colorectal endometriosis, deep infiltrating endometriosis, dysmenorroe, dyspareunia, quality of life
- Medical subject headings
- Endometriosis, Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multidisciplinary laparoscopyProcedure or surgery
Laparoscopic segmental bowel resection for deep infiltrating colorectal endometriosis performed by an experienced colorectal surgeon.
QuestionnairesOther
All 45 patients were asked to complete the Oxford Endometriosis Quality of Life questionnaire, a sexual activity questionnaire, visual analogue scales (VAS) for dysmenorroe, chronic pelvic pain and deep dyspareunia, and to answer questions about medication and fertility, to compare their status before surgery and at the moment of the evaluation (December 2008).
| Study group | Role | What they receive |
|---|---|---|
| 1 | All women (n=45) who had undergone CO2 laser laparoscopic radical excision of deep infiltrating endometriosis with active involvement of the colorectal surgeon performing a bowel resection were selected retrospectively from the list of all patients (n=more than 400) operated at the Leuven University Fertility Centre (LUFc) between September 2004 and July 2006. Receives: Procedure: multidisciplinary laparoscopy; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain; Sexuality; Quality of life; Fertility rate; Complication rate; Recurrence rate
Measured: a median follow-up of 27 months (range 16 - 40 months) after surgery
Secondary outcomes (1)
Economic life circumstances
Measured: a median follow-up of 27 months (range 16 - 40 months) after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2007 (estimated)
- Study startSep 2004
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gasthuisberg
- Sponsor type
- University, hospital or other
- Investigators
- Christel LC Meuleman, MD, Principal investigator, University Hospital Gasthuisberg, Leuven, BelgiumThomas D'Hooghe, MD, PhD, Study director, University Hospital Gasthuisberg, Leuven, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00462176
- Sponsor's protocol ID
- ML2818 - 20/02/2006 a
- Status last verified
- Feb 2009
- First submitted
- 17 Apr 2007
- Last updated
- 20 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Follow-up of Patients After Laparoscopic Segmental Bowel Resection for Deep Infiltrating Colorectal Endometriosis
- ClinicalTrials.gov ID
- NCT00462176
- Acronym / sponsor ID
- ML2818 - 20/02/2006 a
- Conditions
- Endometriosis
- Keywords
- colorectal endometriosis, deep infiltrating endometriosis, dysmenorroe, dyspareunia, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, GasthuisbergUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 18 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is executed to evaluate the outcome on quality of life, pain, sexuality, pregnancy rate and recurrence rate after a fertility sparing multidisciplinary CO2 laser laparoscopic radical excision of deep infiltrating colorectal endometriosis with a bowel resection.
Detailed description
Patients
All women (n=45) who had undergone fertility sparing CO2 laser laparoscopic radical excision of deep infiltrating endometriosis with bowel resection were selected retrospectively from the list of all patients (n=more than 500, of whom slightly more than 50% with endometriosis) operated at the Leuven University Fertility Centre (LUFc) between September 2004 and September 2006.
Questionnaires
All 45 patients were asked to complete the Oxford Endometriosis Quality of Life questionnaire (27), a sexual activity questionnaire (28), visual analogue scales (VAS) for dysmenorroe, chronic pelvic pain and deep dyspareunia, and to answer questions about medication and fertility, to compare their status before surgery and at the moment of the evaluation (December 2008).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: multidisciplinary laparoscopy, Other: QuestionnairesAll women (n=45) who had undergone CO2 laser laparoscopic radical excision of deep infiltrating endometriosis with active involvement of the colorectal surgeon performing a bowel resection were selected retrospectively from the list of all patients (n=more than 400) operated at the Leuven University Fertility Centre (LUFc) between September 2004 and July 2006. |
Who may qualify
- Ages
- 19 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All women (n=45) who had undergone CO2 laser laparoscopic radical excision of deep infiltrating endometriosis with active involvement of the colorectal surgeon performing a bowel resection were selected retrospectively from the list of all patients (n=more than 400) operated at the Leuven University Fertility Centre (LUFc) between September 2004 and July 2006.
Key inclusion criteria (4 listed)
- Patients suffering from deep infiltrating endometriosis with colorectal extension
- Who had undergone CO2 laser laparoscopic radical excision of the endometriosis
- with bowel resection performed by the colorectal surgeon
- between September 2004 and July 2006.
Key exclusion criteria (1 listed)
- Patients without bowel resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multidisciplinary laparoscopyLaparoscopic segmental bowel resection for deep infiltrating colorectal endometriosis performed by an experienced colorectal surgeon. | Procedure or surgery | 1 |
| QuestionnairesAll 45 patients were asked to complete the Oxford Endometriosis Quality of Life questionnaire, a sexual activity questionnaire, visual analogue scales (VAS) for dysmenorroe, chronic pelvic pain and deep dyspareunia, and to answer questions about medication and fertility, to compare their status before surgery and at the moment of the evaluation (December 2008). | Other | 1 |
Primary outcome
Pain; Sexuality; Quality of life; Fertility rate; Complication rate; Recurrence rate
Time frame: a median follow-up of 27 months (range 16 - 40 months) after surgery
1 secondary outcome
Economic life circumstances
Time frame: a median follow-up of 27 months (range 16 - 40 months) after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christel LC Meuleman, MD principal investigator
University Hospital Gasthuisberg, Leuven, Belgium
Thomas D'Hooghe, MD, PhD study director
University Hospital Gasthuisberg, Leuven, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by University Hospital, Gasthuisberg at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain; Sexuality; Quality of life; Fertility rate; Complication rate; Recurrence rate (time frame: a median follow-up of 27 months (range 16 - 40 months) after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2009.